FDA product code GHR: Reagent, Platelet Aggregation
GHR is the FDA product code for reagent, platelet aggregation. It is a Class II device, regulated under 21 CFR 864.5700 and reviewed by the Hematology panel. FDA has cleared 11 510(k) submissions under GHR, from 3 different applicants. The average 510(k) review took 82 days (median 84). FDA has posted 2 recalls for GHR devices.
Classification
| Field | Value |
|---|---|
| Device name | Reagent, Platelet Aggregation |
| Device class | Class II |
| Regulation | 21 CFR 864.5700 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GHR clearance
Top GHR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 6 | 2007-02-23 |
| Chrono-Log Corp. | 3 | 1992-08-26 |
| Medical Diagnostic Technologies, Inc. | 2 | 1991-03-19 |
Most recent GHR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K061991 | Helena Laboratories | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA | 2007-02-23 | 225 |
| K952252 | Helena Laboratories | ADP REAGENT, MODIFIED | 1995-09-08 | 116 |
| K922800 | Chrono-Log Corp. | PLATELET AGGREGATION REAGENTS | 1992-08-26 | 77 |
| K910680 | Helena Laboratories | EPINEPHRINE REAGENT, CAT. NO. 5367 | 1991-05-20 | 94 |
| K910800 | Helena Laboratories | ADP REAGENT | 1991-05-20 | 84 |
Recalls for GHR devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 2 still open. Most recent: 2018-05-23.
| Year | Recalls |
|---|---|
| 2018 | 2 |
Frequently asked questions
What is FDA product code GHR?
GHR is the FDA product code for reagent, platelet aggregation. It is a Class II device, regulated under 21 CFR 864.5700 and reviewed by the Hematology panel.
What device class is GHR?
Class II, regulation 21 CFR 864.5700. Typical premarket route: 510(k).
How long does a 510(k) take for product code GHR?
Across 11 cleared submissions the average was 82 days from receipt to decision (median 84).
Which companies have the most GHR clearances?
Helena Laboratories (6); Chrono-Log Corp. (3); Medical Diagnostic Technologies, Inc. (2).
Have GHR devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2018-05-23.
Next steps
- Run an FDA pathway report with predicate devices for product code GHR
- Run a recall and safety report across every GHR manufacturer
- Watch product code GHR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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